A Clinical Study Testing the Safety, Properties, and Treatment Effects of an Antibody Drug Conjugate ABBV-3373 in Comparison with the Antibody Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis

• Register: EUCTR
• Last refreshed on: 9 November 2020
• Main ID: EUCTR2018-003053-21-PL
• Date of registration: 16/04/2019
• Prospective Registration: Yes
• Primary sponsor: AbbVie Deutschland GmbH & Co. KG
• Public title: A Clinical Study Testing the Safety, Properties, and Treatment Effects of an Antibody Drug Conjugate ABBV-3373 in Comparison with the Antibody Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis
• Scientific title: Randomized, Double-Blind, Double-Dummy, Active Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Subjects with Moderate to Severe Rheumatoid Arthritis
• Date of first enrolment: 27/06/2019
• Target sample size: 45
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-003053-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: yes Other trial design description: Double dummy If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Israel, Poland, Puerto Rico, United States

Contacts

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
1. Adult male or female, between 18 and 75 years of age inclusive at Screening.
2. Subject has the clinical diagnosis of RA for > 3 months based on the 1987 ACR classification criteria or 2010 ACR/European League against Rheumatism (EULAR) criteria.
3. Subject meets the following disease activity criteria: = 4 swollen joints (based on 28 joint count) and = 4 tender joints (based on 28 joint count) at Screening and BL Visits; and DAS28(CRP) = 3.2 at Screening.
4. Subject has an incomplete response to MTX. Subjects must have been on oral or parenteral MTX therapy = 3 months and on a stable prescription of 15 to 25 mg/week (or = 10 mg/week in subjects intolerant of MTX at doses = 15 mg/week) for = 4 weeks prior to the first dose of study drug. Subject must be expected to be able to continue on stable dose of MTX for the duration of study participation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion criteria:
1. Subjects previously exposed to adalimumab or other anti-TNF biologics.
2. Subjects previously exposed to non-anti-TNF biologics or targeted synthetic DMARDs for RA, with exception of subjects exposed for less than 3 months and terminated not due to lack of efficacy or intolerability.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Moderate to Severe Rheumatoid Arthritis
MedDRA version: 21.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Intervention(s)

Product Code: ABBV-3373
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: ABBV-3373
Current Sponsor code: ABBV-3373
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Powder for solution for injection
Route of administration of the placebo: Intravenous use

Trade Name: Humira (adalimumab)
Product Name: Adalimumab
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: Humira
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: 1. To assess the safety, tolerability, and efficacy of ABBV-3373 administered every other week (eow) intravenously (IV) in subjects with moderately to severely active RA on background MTX.
2. To compare clinical efficacy of ABBV-3373 with adalimumab and to test the concept that an anti-TNF antibody-drug-conjugate has the potential to provide superior efficacy than the traditional anti-TNF antibody in RA.

Primary end point(s): The change in disease activity score (DAS)28 (C-reactive protein [CRP]) from Baseline (BL) at Week 12 for ABBV-3373 and adalimumab.

Secondary Objective: 3. To compare adalimumab with synthetic control to establish assay sensitivity.
4. To assess the pharmacokinetics (PK), pharmacodynamics and immunogenicity of ABBV-3373.
5. To assess the durability of the treatment effect of ABBV-3373 after discontinuation.

Timepoint(s) of evaluation of this end point: Week 12

Secondary Outcome(s)

Secondary end point(s): 1. Change in clinical disease activity index (CDAI) from BL at Week 12 for ABBV-3373 and adalimumab.
2. Change in simplified disease activity index (SDAI) from BL at Week 12 for ABBV-3373 and adalimumab.
3. Change in DAS28 erythrocyte sedimentation rate [ESR] from BL at Week 12 for ABBV-3373 and adalimumab.
4. Proportion of subjects achieving a low disease activity (LDA) (DAS28 [CRP] =3.2) at Week 12 for ABBV-3373 and adalimumab.
5. Proportion of subjects achieving American College of Rheumatology (ACR) 50 at Week 12 for ABBV-3373 and adalimumab.

Timepoint(s) of evaluation of this end point: Week 12

Secondary ID(s)

M16-560

Source(s) of Monetary Support

Abbvie Inc.

Ethics review

Status: Approved
Approval date: 27/06/2019
Contact: